Title 49—Transportation--Volume 1
PART 173—SHIPPERS—GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS
§ 173.411   Industrial packages.
(a) General. Each industrial package must comply with the requirements of this section which specifies package tests, and record retention applicable to Industrial Package Type 1 (Type IP-1), Industrial Package Type 2 (Type IP-2), and Industrial Package Type 3 (Type IP-3).
(b) Industrial package certification and tests. (1) Each Type IP-1 package must meet the general design requirements prescribed in § 173.410.
(2) Each Type IP-2 package must meet the general design requirements prescribed in § 173.410 and when subjected to the tests specified in § 173.465(c) and (d) or evaluated against these tests by any of the methods authorized by § 173.461(a), must prevent:
(i) Loss or dispersal of the radioactive contents; and
(ii) A significant increase in the radiation levels recorded or calculated at the external surfaces for the condition before the test.
(3) Each Type IP-3 package must meet the requirements for Type IP-1 and Type IP-2 packages, and must meet the requirements specified in § 173.412(a) through (j).
(4) A portable tank may be used as a Type IP-2 or Type IP-3 package provided that:
(i) It meets the requirements for Type IP-1 packages specified in paragraph (b)(1);
(ii) It meets the requirements prescribed in Chapter 6.7 of the United Nations Recommendations on the Transport of Dangerous Goods, (IBR, see § 171.7 of this subchapter), “Requirements for the Design, Construction, Inspection and Testing of Portable Tanks and Multiple-Element Gas Containers (MEGCs),” or other requirements at least equivalent to those standards;
(iii) It is capable of withstanding a test pressure of 265 kPa (38.4 psia); and
(iv) It is designed so that any additional shielding which is provided must be capable of withstanding the static and dynamic stresses resulting from handling and routine conditions of transport and of preventing more than a 20% increase in the maximum radiation level at any external surface of the portable tanks.
(5) A cargo tank or a tank car may be used as Type IP-2 or Type IP-3 package for transporting LSA-I and LSA-II liquids and gases as prescribed in Table 6 of § 173.427, provided that:
(i) It meets the requirements for a Type IP-1 package specified in paragraph (b)(1);
(ii) It is capable of withstanding a test pressure of 265 kPa (38.4 psia); and
(iii) It is designed so that any additional shielding which is provided must be capable of withstanding the static and dynamic stresses resulting from handling and routine conditions of transport and of preventing more than a 20% increase in the maximum radiation level at any external surface of the tanks.
(6) A freight container may be used as Type IP-2 or Type IP-3 packages provided:
(i) The radioactive contents are restricted to solid materials;
(ii) It meets the requirements for a Type IP-1 packages specified in paragraph (b)(1); and
(iii) It meets the standards prescribed in the International Organization for Standardization document ISO 1496-1: “Series 1 Freight Containers—Specifications and Testing—Part 1: General Cargo Containers; excluding dimensions and ratings (IBR, see § 171.7 of this subchapter). It must be designed such that if subjected to the tests prescribed in that document and the accelerations occurring during routine conditions of transport it would prevent:
(A) Loss or dispersal of the radioactive contents; and
(B) More than a 20% increase in the maximum radiation level at any external surface of the freight containers.
(7) A metal intermediate bulk containers may be used as a Type IP-2 or Type IP-3 package, provided:
(i) It meets the requirements for a Type IP-1 package specified in paragraph (b)(1); and
(ii) It meets the requirements prescribed in Chapter 6.5 of the United Nations Recommendations on the Transport of Dangerous Goods, (IBR, see § 171.7 of this subchapter), “Requirements for the Construction and Testing of Intermediate Bulk Containers,” for Packing Group I or II, and if subjected to the tests prescribed in that document, but with the drop test conducted in the most damaging orientation, it would prevent:
(A) Loss or dispersal of the radioactive contents; and
(B) More than a 20% increase in the maximum radiation level at any external surface of the intermediate bulk container.
(c) Except for Type IP-1 packages, each offeror of an industrial package must maintain on file for at least two years after the offeror's latest shipment, and must provide to the Associate Administrator on request, complete documentation of tests and an engineering evaluation or comparative data showing that the construction methods, package design, and materials of construction comply with that specification.
§ 173.412   Additional design requirements for Type A packages.
In addition to meeting the general design requirements prescribed in § 173.410, each Type A packaging must be designed so that—
(a) The outside of the packaging incorporates a feature, such as a seal, that is not readily breakable, and that, while intact, is evidence that the package has not been opened. In the case of packages shipped in closed transport vehicles in exclusive use, the cargo compartment, instead of the individual packages, may be sealed.
(b) The smallest external dimension of the package is not less than 10 cm (4 inches).
(c) Containment and shielding is maintained during transportation and storage in a temperature range of −40 °C (−40 °F) to 70 °C (158 °F). Special attention shall be given to liquid contents and to the potential degradation of the packaging materials within the temperature range.
(d) The packaging must include a containment system securely closed by a positive fastening device that cannot be opened unintentionally or by pressure that may arise within the package during normal transport. Special form Class 7 (radioactive) material, as demonstrated in accordance with § 173.469, may be considered as a component of the containment system. If the containment system forms a separate unit of the package, it must be securely closed by a positive fastening device that is independent of any other part of the package.
(e) For each component of the containment system account is taken, where applicable, of radiolytic decomposition of materials and the generation of gas by chemical reaction and radiolysis.
(f) The containment system will retain its radioactive contents under the reduction of ambient pressure to 60 kPa (8.7 psia).
(g) Each valve, other than a pressure relief device, is provided with an enclosure to retain any leakage.
(h) Any radiation shield that encloses a component of the packaging specified as part of the containment system will prevent the unintentional escape of that component from the shield.
(i) Failure of any tie-down attachment that is a structural part of the packaging, under both normal and accident conditions, must not impair the ability of the package to meet other requirements of this subpart.
(j) When evaluated against the performance requirements of this section and the tests specified in § 173.465 or using any of the methods authorized by § 173.461(a), the packaging will prevent—
(1) Loss or dispersal of the radioactive contents; and
(2) A significant increase in the radiation levels recorded or calculated at the external surfaces for the condition before the test.
(k) Each packaging designed for liquids will—
(1) Be designed to provide for ullage to accommodate variations in temperature of the contents, dynamic effects and filling dynamics;
(2) Meet the conditions prescribed in paragraph (j) of this section when subjected to the tests specified in § 173.466 or evaluated against these tests by any of the methods authorized by § 173.461(a); and
(3) Either—
(i) Have sufficient suitable absorbent material to absorb twice the volume of the liquid contents. The absorbent material must be compatible with the package contents and suitably positioned to contact the liquid in the event of leakage; or
(ii) Have a containment system composed of primary inner and secondary outer containment components designed to enclose the liquid contents completely and ensure retention of the liquid within the secondary outer component in the event that the primary inner component leaks.
(l) Each package designed for gases, other than tritium not exceeding 40 TBq (1080Ci) or noble gases not exceeding the A 2 value appropriate for the noble gas, will be able to prevent loss or dispersal of contents when the package is subjected to the tests prescribed in § 173.466 or evaluated against these tests by any of the methods authorized by § 173.461(a).
§ 173.413   Requirements for Type B packages.
Except as provided in § 173.416, each Type B(U) or Type B(M) package must be designed and constructed to meet the applicable requirements specified in 10 CFR part 71.
§ 173.415   Authorized Type A packages.
The following packages are authorized for shipment if they do not contain quantities exceeding A 1 or A 2 as appropriate:
(a) DOT Specification 7A (see § 178.350 of this subchapter) Type A general packaging. Each offeror of a Specification 7A package must maintain on file for at least two years after the offeror's latest shipment, and shall provide to DOT on request, one of the following:
(1) A description of the package showing materials of construction, dimensions, weight, closure and closure materials (including gaskets, tape, etc.) of each item of the containment system, shielding and packing materials used in normal transportation, and the following:
(i) If the packaging is subjected to the physical tests of § 173.465, and if applicable, § 173.466, documentation of testing, including date, place of test, signature of testers, a detailed description of each test performed including equipment used, and the damage to each item of the containment system resulting from the tests, or
(ii) For any other demonstration of compliance with tests authorized in § 173.461, a detailed analysis which shows that, for the contents being shipped, the package meets the pertinent design and performance requirements for a DOT 7A Type A specification package.
(2) If the offeror has obtained the packaging from another person who meets the definition of “packaging manufacturer” in § 178.350(c) of this subchapter, a certification from the packaging manufacturer that the package meets all the requirements of § 178.350 for the radioactive contents presented for transport and a copy of documents maintained by the packaging manufacturer that meet the requirements of paragraph (a)(1) of this section.
(b) Any other Type A packaging that also meets the applicable standards for fissile materials in 10 CFR part 71 and is used in accordance with § 173.471.
(c) Any Type B(U) or Type B(M) packaging authorized pursuant to § 173.416.
(d) Any foreign-made packaging that meets the standards in the ” IAEA Regulations for the Safe Transport of Radioactive Material, SSR-6” (IBR, see § 171.7 of this subchapter) and bears the marking “Type A”. Such packagings may be used for domestic and export shipments of Class 7 (radioactive) materials provided the offeror obtains the applicable documentation of tests and engineering evaluations and maintains the documentation on file in accordance with paragraph (a) of this section. These packagings must conform with requirements of the country of origin (as indicated by the packaging marking) and the IAEA regulations applicable to Type A packagings.
§ 173.416   Authorized Type B packages.
Each of the following packages is authorized for shipment of quantities exceeding A 1 or A 2 , as appropriate:
(a) Any Type B(U) or Type B(M) packaging that meets the applicable requirements of 10 CFR part 71 and that has been approved by the U.S. Nuclear Regulatory Commission may be shipped pursuant to § 173.471.
(b) Any Type B(U) or B(M) packaging that meets the applicable requirements in “IAEA Regulations for the Safe Transport of Radioactive Material, SSR-6” (IBR, see § 171.7 of this subchapter) and for which the foreign Competent Authority Certificate has been revalidated by DOT pursuant to § 173.473. These packagings are authorized only for export and import shipments.
(c) A package approved by the U.S. Nuclear Regulatory Commission under a special package authorization granted in accordance with 10 CFR 71.41(d) provided it is offered only for domestic transportation in accordance with the requirements in § 173.471(b) and (c).
§ 173.417   Authorized fissile materials packages.
(a) Except as provided in § 173.453, fissile materials containing not more than A 1 or A 2 as appropriate, must be packaged in one of the following packagings:
(1)(i) Any packaging listed in § 173.415, limited to the Class 7 (radioactive) materials specified in 10 CFR part 71, subpart C;
(ii) Any Type AF, Type B(U)F, or Type B(M)F packaging that meets the applicable standards for fissile material packages in 10 CFR part 71; or
(iii) Any Type AF, Type B(U)F, or Type B(M)F packaging that meets the applicable requirements for fissile material packages in Section VI of the International Atomic Energy Agency “Regulations for the Safe Transport of Radioactive Material, SSR-6 (IBR, see § 171.7 of this subchapter),” and for which the foreign Competent Authority certificate has been revalidated by the U.S. Competent Authority, in accordance with § 173.473. These packages are authorized only for export and import shipments.
(2) A residual “heel” of enriched solid uranium hexafluoride may be transported without a protective overpack in any metal cylinder that meets both the requirements of § 173.415 and § 178.350 of this subchapter for Specification 7A Type A packaging, and the requirements of § 173.420 for packagings containing greater than 0.1 kg of uranium hexafluoride. Any such shipment must be made in accordance with Table 2, as follows:
Table 2—Allowable Content of Uranium Hexafluoride (UF 6 “Heel” in a Specification 7A Cylinder)
1 10 ton.
2 14 ton
(b) Fissile Class 7 (radioactive) materials with radioactive content exceeding A 1 or A 2 must be packaged in one of the following packagings:
(1) Type B(U), or Type B(M) packaging that meets the standards for packaging of fissile materials in 10 CFR part 71, and is approved by the U.S. Nuclear Regulatory Commission and used in accordance with § 173.471;
(2) Type B(U) or Type B(M) packaging that also meets the applicable requirements for fissile material packaging in Section VI of the International Atomic Energy Agency “Regulations for the Safe Transport of Radioactive Material, SSR-6,” and for which the foreign Competent Authority certificate has been revalidated by the U.S. Competent Authority in accordance with § 173.473. These packagings are authorized only for import and export shipments.
(c) A package approved by the U.S. Nuclear Regulatory Commission under a special package authorization granted in accordance with 10 CFR 71.41(d) provided it is offered only for domestic transportation in accordance with the requirements in § 173.471(b) and (c).
§ 173.418   Authorized packages—pyrophoric Class 7 (radioactive) materials.
Pyrophoric Class 7 (radioactive) materials, as referenced in the § 172.101 table of this subchapter, in quantities not exceeding A 2 per package must be transported in DOT Specification 7A packagings constructed of materials that will not react with, nor be decomposed by, the contents. Contents of the package must be—
(a) In solid form and must not be fissile unless excepted by § 173.453;
(b) Contained in sealed and corrosion resistant receptacles with positive closures (friction or slip-fit covers or stoppers are not authorized);
(c) Free of water and contaminants that would increase the reactivity of the material; and
(d) Inerted to prevent self-ignition during transport by either—
(1) Mixing with large volumes of inerting materials, such as graphite, dry sand, or other suitable inerting material, or blended into a matrix of hardened concrete; or
(2) Filling the innermost receptacle with an appropriate inert gas or liquid.
(e) Pyrophoric Class 7 (radioactive) materials transported by aircraft must be packaged in Type B packages.
§ 173.419   Authorized packages—oxidizing Class 7 (radioactive) materials.
(a) An oxidizing Class 7 (radioactive) material, as referenced in the § 172.101 table of this subchapter, is authorized in quantities not exceeding an A 2 per package, in a DOT Specification 7A package provided that—
(1) The contents are:
(i) Not fissile;
(ii) Packed in inside packagings of glass, metal or compatible plastic; and
(iii) Cushioned with a material that will not react with the contents; and
(2) The outside packaging is made of wood, metal, or plastic.
(b) The package must be capable of meeting the applicable test requirements of § 173.465 without leakage of contents.
(c) For shipment by air, the maximum quantity in any package may not exceed 11.3 kg (25 pounds).
§ 173.420   Uranium hexafluoride (fissile, fissile excepted and non-fissile).
(a) In addition to any other applicable requirements of this subchapter, quantities greater than 0.1 kg of fissile, fissile excepted or non-fissile uranium hexafluoride must be offered for transportation as follows:
(1) Before initial filling and during periodic inspection and test, packagings must be cleaned in accordance with American National Standard N14.1 (IBR, see § 171.7 of this subchapter).
(2) Packagings must be designed, fabricated, inspected, tested and marked in accordance with—
(i) American National Standard N14.1 in effect at the time the packaging was manufactured; or
(ii) [Reserved]
(iii) Section VIII of the ASME Code (IBR, see § 171.7 of this subchapter), provided the packaging—
(A) Was manufactured on or before June 30, 1987;
(B) Conforms to the edition of the ASME Code in effect at the time the packaging was manufactured;
(C) Is used within its original design limitations; and
(D) Has shell and head thicknesses that have not decreased below the minimum value specified in the following table:
(3) Each package shall be designed so that it will:
(i) Withstand a hydraulic test at an internal pressure of at least 1.4 MPa (200 psig) without leakage;
(ii) Withstand the test specified in § 173.465(c) without loss or dispersal of the uranium hexafluoride; and
(iii) Withstand the test specified in 10 CFR 71.73(c)(4) without rupture of the containment system.
(4) Uranium hexafluoride must be in solid form.
(5) The volume of solid uranium hexafluoride, except solid depleted uranium hexafluoride, at 20 °C (68 °F) may not exceed 61% of the certified volumetric capacity of the packaging. The volume of solid depleted uranium hexafluoride at 20 °C (68 °F) may not exceed 62% of the certified volumetric capacity of the packaging.
(6) The pressure in the package at 20 °C (68 °F) must be less than 101.3 kPa (14.7 psia).
(b) Each packaging for uranium hexafluoride must be periodically inspected, tested, marked and otherwise conform with the American National Standard N14.1.
(c) Each repair to a packaging for uranium hexafluoride must be performed in accordance with the American National Standard N14.1.
(d) Uranium hexafluoride not exceeding the limits specified in the limited quantity package limits column of table 4 in § 173.425 may be classified as UN 3507, Uranium hexafluoride, radioactive material, excepted package, less than 0.1 kg (0.22 pounds) per package, non-fissile or fissile-excepted, provided that:
(1) The mass of uranium hexafluoride in the package is less than 0.1 kg (0.22 pounds); and
(2) The conditions of §§ 173.24, 173.24a, and 173.421(a) and (d) are met.
(e) For a package containing 0.1 kg or more of UF 6 , the proper shipping name and UN number “Radioactive material, uranium hexafluoride, UN 2978” must be used for the transportation of non-fissile or fissile-excepted uranium hexafluoride and the proper shipping name and UN number “Radioactive material, uranium hexafluoride, fissile, UN 2977” must be used for the transport of fissile uranium hexafluoride.
§ 173.421   Excepted packages for limited quantities of Class 7 (radioactive) materials.
A Class 7 (radioactive) material with an activity per package which does not exceed the limited quantity package limits specified in Table 4 in § 173.425, and its packaging, are excepted from requirements in this subchapter for specification packaging, marking (except for the UN identification number marking requirement described in § 173.422(a)), labeling, and if not a hazardous substance or hazardous waste, shipping papers, and the requirements of this subpart if:
(a) Each package meets the general design requirements of § 173.410;
(b) The radiation level at any point on the external surface of the package does not exceed 0.005 mSv/h (0.5 mrem/h);
(c) The non-fixed contamination on the external surface of the package does not exceed the limits specified in § 173.443(a);
(d) The outside of the inner packaging or, if there is no inner packaging, the outside of the packaging itself bears the marking “Radioactive;”
(e) The package does not contain fissile material unless excepted by § 173.453; and
(f) The material is otherwise prepared for shipment as specified in accordance with § 173.422.
§ 173.422   Additional requirements for excepted packages containing Class 7 (radioactive) materials.
An excepted package of Class 7 (radioactive) material that is prepared for shipment under the provisions of § 173.421, § 173.424, § 173.426, or § 173.428, or a small quantity of another hazard class transported by highway or rail (as defined in § 173.4) which also meets the requirements of one of these sections, is not subject to any additional requirements of this subchapter, except for the following:
(a) The outside of each package must be marked with:
(1) The UN identification number for the material preceded by the letters UN, as shown in column (4) of the Hazardous Materials Table in § 172.101 of this subchapter; and
(2) The letters “RQ” on a non-bulk packaging containing a hazardous substance.
(b) Sections 171.15 and 171.16 of this subchapter, pertaining to the reporting of incidents;
(c) Sections 174.750, 175.705, and 176.710 of this subchapter (depending on the mode of transportation), pertaining to the reporting of decontamination;
(d) The training requirements of subpart H of part 172 of this subchapter;
(e) For a material that meets the definition of a hazardous substance or a hazardous waste, the shipping paper requirements of subpart C of part 172 of this subchapter, except that such shipments are not subject to shipping paper requirements applicable to Class 7 (radioactive) materials in §§ 172.202(a)(5), 172.202(a)(6), 172.203(d) and 172.204(c)(4); and
(f) For transportation by vessel—
(1) The following information must be shown on a special transport document such as a bill of lading, air waybill, or other similar document:
(i) The UN identification number for the material preceded by the letters “UN”, as shown in column (4) of the Hazardous Materials Table in § 172.101 of this subchapter; and
(ii) The name and address of the consignor and the consignee.
(2) The certificate requirements in § 176.27 must be met.
§ 173.423   Requirements for multiple hazard limited quantity Class 7 (radioactive) materials.
(a) Except as provided in § 173.4, when a limited quantity radioactive material meets the definition of another hazard class or division, it must be—
(1) Classed for the additional hazard;
(2) Packaged to conform with the requirements specified in § 173.421(a) through (e) or § 173.424(a) through (g), as appropriate; and
(3) Offered for transportation in accordance with the requirements applicable to the hazard for which it is classed.
(b) A limited quantity Class 7 (radioactive) material which is classed other than Class 7 in accordance with this subchapter is excepted from the requirements of §§ 173.422(a), 172.203(d), and 172.204(c)(4) of this subchapter if the entry “Limited quantity radioactive material” appears on the shipping paper in association with the basic description.
§ 173.424   Excepted packages for radioactive instruments and articles.
A radioactive instrument or article and its packaging are excepted from requirements in this subchapter for specification packaging, labeling, marking (except for the UN identification number marking requirement described in § 173.422(a)), and if not a hazardous substance or hazardous waste, shipping papers and the requirements of this subpart if:
(a) Each package meets the general design requirements of § 173.410;
(b) The activity of the instrument or article does not exceed the relevant limit listed in Table 4 in § 173.425;
(c) The total activity per package does not exceed the relevant limit listed in Table 4 in § 173.425;
(d) The radiation level at 10 cm (4 in) from any point on the external surface of any unpackaged instrument or article does not exceed 0.1 mSv/hour (10 mrem/hour);
(e) The active material is completely enclosed by non-active components (a device performing the sole function of containing radioactive material shall not be considered to be an instrument or manufactured article);
(f) The radiation level at any point on the external surface of a package bearing the article or instrument does not exceed 0.005 mSv/hour (0.5 mrem/hour), or, for exclusive use domestic shipments, 0.02 mSv/hour (2 mrem/hour);
(g) The nonfixed (removable) radioactive surface contamination on the external surface of the package does not exceed the limits specified in § 173.443(a);
(h) Except as provided in § 173.426, the package does not contain more than 15 g of uranium-235; and
(i) The package is otherwise prepared for shipment as specified in § 173.422.
§ 173.425   Table of activity limits—excepted quantities and articles.
The limits applicable to instruments, articles, and limited quantities subject to exceptions under §§ 173.421 and 173.424 are set forth in table 4 as follows:
Table 4—Activity Limits for Limited Quantities, Instruments, and Articles
1 For mixtures of radionuclides see § 173.433(d).
2 These values also apply to tritium in activated luminous paint and tritium adsorbed on solid carriers.
§ 173.426   Excepted packages for articles containing natural uranium or thorium.
A manufactured article in which the sole Class 7 (radioactive) material content is natural uranium, unirradiated depleted uranium or natural thorium, and its packaging, are excepted from the requirements in this subchapter for specification packaging, labeling, marking (except for the UN identification number marking requirement described in § 173.422(a)), and if not a hazardous substance or hazardous waste, shipping papers and the requirements of this subpart if:
(a) Each package meets the general design requirements of § 173.410;
(b) The outer surface of the uranium or thorium is enclosed in an inactive sheath made of metal or other durable protective material;
(c) The conditions specified in § 173.421 (b), (c) and (d) are met; and
(d) The article is otherwise prepared for shipment as specified in § 173.422.
§ 173.427   Transport requirements for low specific activity (LSA) Class 7 (radioactive) material and surface contaminated objects (SCO).
(a) In addition to other applicable requirements specified in this subchapter, LSA material and SCO must be transported in accordance with the following conditions:
(1) The external dose rate may not exceed an external radiation level of 10 mSv/h (1 rem/h) at 3 m (10 feet) from the unshielded material;
(2) The quantity of LSA material and SCO transported in any single conveyance may not exceed the limits specified in Table 5;
(3) LSA material and SCO that are or contain fissile material must conform to the applicable requirements of § 173.453;
(4) Packaged and unpackaged Class 7 (radioactive) materials must conform to the contamination control limits specified in § 173.443;
(5) External radiation levels may not exceed those specified in § 173.441; and
(6) For LSA material and SCO consigned as exclusive use:
(i) Shipments must be loaded by the consignor and unloaded by the consignee from the conveyance or freight container in which originally loaded;
(ii) There may be no loose radioactive material in the conveyance; however, when the conveyance is the packaging, there may not be any leakage of radioactive material from the conveyance;
(iii) Packaged and unpackaged Class 7 (radioactive) material must be braced so as to prevent shifting of lading under conditions normally incident to transportation;
(iv) Specific instructions for maintenance of exclusive use shipment controls shall be provided by the offeror to the carrier. Such instructions must be included with the shipping paper information;
(v) The shipment must be placarded in accordance with subpart F of part 172 of this subchapter;
(vi) For domestic transportation only, packaged and unpackaged Class 7 (radioactive) material containing less than an A 2 quantity are excepted from the marking and labeling requirements of this subchapter, other than the subsidiary hazard labeling required in § 172.402(d). However, the exterior of each package or unpackaged Class 7 (radioactive) material must be stenciled or otherwise marked “RADIOACTIVE—LSA” or “RADIOACTIVE—SCO”, as appropriate, and packages or unpackaged Class 7 (radioactive) material that contain a hazardous substance must be stenciled or otherwise marked with the letters “RQ” in association with the description in this paragraph (a)(6)(vi); and
(vii) Transportation by aircraft is prohibited except when transported in an industrial package in accordance with Table 6 of this section, or in an authorized Type A or Type B package.
(b) Except as provided in paragraph (c) or (d) of this section, LSA material and SCO must be packaged as follows:
(1) In an industrial package (Type IP-1, Type IP-2 or Type IP-3; § 173.411), subject to the limitations of Table 6;
(2) In a DOT Specification 7A (§ 178.350 of this subchapter) Type A package;
(3) In any Type B(U) or B(M) packaging authorized pursuant to § 173.416;
(4) For domestic transportation of an exclusive use shipment that is less than an A 2 quantity, in a packaging which meets the requirements of § 173.410; or
(5) In portable tanks, cargo tanks and tank cars, as provided in § 173.411(b)(4) and (5), respectively.
(c) LSA-I material and SCO-I may be transported unpackaged under the following conditions:
(1) All unpackaged material, other than ores containing only naturally occurring radionuclides, must be transported in such a manner that under routine conditions of transport there will be no escape of the radioactive contents from the conveyance nor will there be any loss of shielding;
(2) Each conveyance must be under exclusive use, except when only transporting SCO-I on which the contamination on the accessible and the inaccessible surfaces is not greater than 4.0 Bq/cm 2 for beta and gamma emitters and low toxicity alpha emitters and 0.4 Bq/cm 2 for all other alpha emitters;
(3) For SCO-I where it is reasonable to suspect that non-fixed contamination may exist on inaccessible surfaces in excess of the values specified in paragraph (c)(2) of this section, measures shall be taken to ensure that the radioactive material is not released into the conveyance or to the environment; and
(4) The highway or rail conveyance must be placarded in accordance with subpart F of part 172 of this subchapter.
(d) LSA material and SCO that exceed the packaging limits in this section must be packaged in accordance with 10 CFR part 71.
(e) Tables 5 and 6 are as follows:
Table 5—Conveyance Activity Limits for LSA Material and SCO
Table 6—Industrial Package Integrity Requirements for LSA Material and SCO
§ 173.428   Empty Class 7 (radioactive) materials packaging.
A packaging which previously contained Class 7 (radioactive) materials and has been emptied of contents as far as practical, is excepted from the shipping paper and marking (except for the UN identification number marking requirement described in § 173.422(a)) requirements of this subchapter, provided that—
(a) The packaging meets the requirements of § 173.421 (b), (c), and (e) of this subpart;
(b) The packaging is in unimpaired condition and is securely closed so that there will be no leakage of Class 7 (radioactive) material under conditions normally incident to transportation;
(c) The outer surface of any uranium or thorium in its structure is covered with an inactive sheath made of metal or some other substantial material;
(d) Internal contamination does not exceed 100 times the limits in § 173.443(a);
(e) Any labels previously applied in conformance with subpart E of part 172 of this subchapter are removed, obliterated, or covered and the “Empty” label prescribed in § 172.450 of this subchapter is affixed to the packaging; and
(f) The packaging is prepared for shipment as specified in § 173.422.
§ 173.431   Activity limits for Type A and Type B packages.
(a) Except for LSA material and SCO, a Type A package may not contain a quantity of Class 7 (radioactive) materials greater than A 1 for special form Class 7 (radioactive) material or A 2 for normal form Class 7 (radioactive) material as listed in § 173.435, or, for Class 7 (radioactive) materials not listed in § 173.435, as determined in accordance with § 173.433.
(b) The limits on activity contained in a Type B(U) or Type B(M) package are those prescribed in §§ 173.416 and 173.417, or in the applicable approval certificate under § 173.471, § 173.472 or § 173.473.
§ 173.433   Requirements for determining basic radionuclide values, and for the listing of radionuclides on shipping papers and labels.
(a) For individual radionuclides listed in the table in § 173.435 and § 173.436:
(1) A 1 and A 2 values are given in the table in § 173.435; and
(2) Activity concentration exemption values and consignment activity exemption values are given in the table in § 173.436.
(b) For individual radionuclides which are not listed in the tables in § 173.435 or § 173.436 or for which no relevant data are available:
(1) the radionuclide values in Tables 7 or 8 of this section may be used; or
(2) other basic radionuclide values may be used provided they are first approved by the Associate Administrator or, for international transport, multilateral approval is obtained from the pertinent Competent Authorities.
(c) In calculating A1 and A 2 values for approval in accordance with paragraph (b)(2) of this section:
(1) It is permissible to use an A 2 value calculated using a dose coefficient for the appropriate lung absorption type, as recommended by the International Commission on Radiological Protection, if the chemical forms of each radionuclide under both normal and accident conditions of transport are taken into consideration.
(2) A single radioactive decay chain in which the radionuclides are present in their naturally-occurring proportions, and in which no daughter nuclide has a half life either longer than 10 days or longer than that of the parent nuclide, will be considered as a single radionuclide, and the activity to be taken into account and the A 1 or A 2 value to be applied will be those corresponding to the parent nuclide of that chain. Otherwise, the parent and daughter nuclides will be considered as a mixture of different nuclides.
(d) Mixtures of radionuclides whose identities and respective activities are known must conform to the following conditions:
(1) For special form Class 7 (radioactive) material, the activity which may be transported in a Type A package must satisfy:
(2) For normal form Class 7 (radioactive) material, the activity which may be transported in a Type A package must satisfy:
(3) If the package contains both special and normal form Class 7 (radioactive) material, the activity which may be transported in a Type A package must satisfy:
(4) Alternatively, the A 1 value for a mixture of special form material may be determined as follows:
(5) Alternatively, the A 2 value for mixtures of normal form material may be determined as follows:
(6) The exempt activity concentration for mixtures of nuclides may be determined as follows:
(7) The activity limit for an exempt consignment for mixtures of nuclides may be determined as follows:
(e) When the identity of each nuclide is known but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest A 1 or A 2 value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraphs (d)(1) through (d)(5) of this section. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest A 1 or A 2 values for the alpha emitters or beta/gamma emitters, respectively.
(f) When the identity of each nuclide is known but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest [A] (activity concentration for exempt material) or A (activity limit for exempt consignment) value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraphs (d)(6) and (d)(7) of this section. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest [A] or A values for the alpha emitters or beta/gamma emitters, respectively.
(g) Shipping papers and labeling. For mixtures of radionuclides, the radionuclides (n) that must be shown on shipping papers and labels in accordance with §§ 172.203 and 172.403 of this subchapter, respectively, must be determined on the basis of the following formula:
(h) Tables 7 and 8 are as follows:
Table 7—General Values for A1 and A2
1 If beta or gamma emitting nuclides are also known to be present, the A1 value of 0.1 TBq (2.7 Ci) should be used.
Table 8—General Exemption Values
§ 173.434   Activity-mass relationships for uranium and natural thorium.
The table of activity-mass relationships for uranium and natural thorium are as follows:
1 The figures for uranium include representative values for the activity of uranium-234 which is concentrated during the enrichment process. The activity for thorium includes the equilibrium concentration of thorium-228.
§ 173.435   Table of A1and A2values for radionuclides.
The table of A 1 and A 2 values for radionuclides is as follows:
a A 1 and/or A 2 values for these parent radionuclides include contributions from daughter nuclides with half-lives less than 10 days as listed in footnote (a) to Table 2 in the “IAEA Regulations for the Safe Transport of Radioactive Material, SSR-6” (IBR, see § 171.7 of this subchapter).
b The values of A 1 and A 2 in curies (Ci) are approximate and for information only; the regulatory standard units are Terabecquerels (TBq), (see § 171.10).
c The activity of Ir-192 in special form may be determined from a measurement of the rate of decay or a measurement of the radiation level at a prescribed distance from the source.
d These values apply only to compounds of uranium that take the chemical form of UF 6 , UO 2 F 2 and UO 2 (NO 3 ) 2 in both normal and accident conditions of transport.
e These values apply only to compounds of uranium that take the chemical form of UO 3 , UF 4 , UCl 4 and hexavalent compounds in both normal and accident conditions of transport.
f These values apply to all compounds of uranium other than those specified in notes (d) and (e) of this table.
g These values apply to unirradiated uranium only.
h [Reserved]
i A 2 = 0.74 TBq (20 Ci) for Mo-99 for domestic use.
§ 173.436   Exempt material activity concentrations and exempt consignment activity limits for radionuclides.
The Table of Exempt material activity concentrations and exempt consignment activity limits for radionuclides is as follows:
a [Reserved]
b Parent nuclides and their progeny included in secular equilibrium are listed as follows:
Sr-90 Y-90
Zr-93 Nb-93m
Zr-97 Nb-97
Ru-106 Rh-106
Ag-108m Ag-108
Cs-137 Ba-137m
Ce-144 Pr-144
Ba-140 La-140
Bi-212 Tl-208 (0.36), Po-212 (0.64)
Pb-210 Bi-210, Po-210
Pb-212 Bi-212, Tl-208 (0.36), Po-212 (0.64)
Rn-222 Po-218, Pb-214, Bi-214, Po-214
Ra-223 Rn-219, Po-215, Pb-211, Bi-211, Tl-207
Ra-224 Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64),
Ra-226 Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210
Ra-228 Ac-228
Th-228 Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Th-229 Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209
Th-nat Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Th-234 Pa-234m
U-230 Th-226, Ra-222, Rn-218, Po-214
U-232 Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
U-235 Th-231
U-238 Th-234, Pa-234m
U-nat Th-234, Pa-234m, U-234, Th-230, Ra-226, Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210
Np-237 Pa-233
Am-242m Am-242
Am-243 Np-239
c [Reserved]
d These values apply only to compounds of uranium that take the chemical form of UF 6 , UO 2 F 2 and UO 2 (NO 3 ) 2 in both normal and accident conditions of transport.
e These values apply only to compounds of uranium that take the chemical form of UO 3 , UF 4 , UCl 4 and hexavalent compounds in both normal and accident conditions of transport.
f These values apply to all compounds of uranium other than those specified in notes (d) and (e) of this table.
g These values apply to unirradiated uranium only.
§ 173.441   Radiation level limitations and exclusive use provisions.
(a) Except as provided in paragraph (b) of this section, each package of Class 7 (radioactive) materials offered for transportation must be designed and prepared for shipment, so that under conditions normally incident to transportation, the radiation level does not exceed 2 mSv/hour (200 mrem/hour) at any point on the external surface of the package, and the transport index does not exceed 10.
(b) A package which exceeds the radiation level limits specified in paragraph (a) of this section must be transported by exclusive use shipment, and the radiation levels for such shipment may not exceed the following during transportation:
(1) 2 mSv/h (200 mrem/h) on the external surface of the package unless the following conditions are met, in which case the limit is 10 mSv/h (1000 mrem/h):
(i) The shipment is made in a closed transport vehicle;
(ii) The package is secured within the vehicle so that its position remains fixed during transportation; and
(iii) There are no loading or unloading operations between the beginning and end of the transportation;
(2) 2 mSv/h (200 mrem/h) at any point on the outer surfaces of the vehicle, including the top and underside of the vehicle; or in the case of a flat-bed style vehicle, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load or enclosure if used, and on the lower external surface of the vehicle;
(3) 0.1 mSv/h (10 mrem/h) at any point 2 m (6.6 feet) from the outer lateral surfaces of the vehicle (excluding the top and underside of the vehicle); or in the case of a flat-bed style vehicle, at any point 2 m (6.6 feet) from the vertical planes projected by the outer edges of the vehicle (excluding the top and underside of the vehicle); and
(4) 0.02 mSv/h (2mrem/h) in any normally occupied space, except that this provision does not apply to carriers if they operate under the provisions of a State or federally regulated radiation protection program and if personnel under their control who are in such an occupied space wear radiation dosimetry devices.
(c) For shipments made under the provisions of paragraph (b) of this section, the offeror shall provide specific written instructions for maintenance of the exclusive use shipment controls to the carrier. The instructions must be included with the shipping paper information. The instructions must be sufficient so that, when followed, they will cause the carrier to avoid actions that will unnecessarily delay delivery or unnecessarily result in increased radiation levels or radiation exposures to transport workers or members of the general public.
(d) Conveyance limits on the sum of package transport indices are as follows:
(1) Except for shipments by cargo aircraft only or by seagoing vessel, the sum of transport indices for a non-exclusive use shipment may not exceed 50.
(2) Where a consignment is transported under exclusive use, there is no limit on the sum of the transport indices aboard a single conveyance. The conditions of paragraphs (b)(2), (b)(3), (b)(4) and (c) must be met.
(3) Provisions for shipments of Class 7 (radioactive) materials by air are described in §§ 175.700-175.705 of this subchapter.
(4) Provisions for shipment of Class 7 (radioactive) materials by vessel are described in §§ 176.700-176.720 of this subchapter.
(e) A package exceeding the maximum surface radiation level or maximum transport index prescribed in paragraph (a) of this section may not be transported by aircraft.
§ 173.442   Thermal limitations.
A package of Class 7 (radioactive) material must be designed, constructed, and loaded so that—
(a) The heat generated within the package by the radioactive contents will not, during conditions normally incident to transport, affect the integrity of the package; and
(b) The temperature of the accessible external surfaces of the loaded package will not, assuming still air in the shade at an ambient temperature of 38 °C (100 °F), exceed either—
(1) 50 °C (122 °F) in other than an exclusive use shipment; or
(2) 85 °C (185 °F) in an exclusive use shipment.
§ 173.443   Contamination control.
(a) The level of non-fixed contamination must be kept as low as reasonably achievable on the external surfaces of each package, conveyance, freight container, and overpack offered for transport, and the internal surfaces of each conveyance, freight container, and overpack in which inner packages or receptacles of Class 7 (radioactive) materials are offered for transport.
(1) Excluding the interior surfaces of the containment system of packages and the internal surfaces of a conveyance, freight container, tank, or intermediate bulk container dedicated to the transport of unpackaged radioactive material in accordance with § 173.427(c) and remaining under that specific exclusive use, the level of non-fixed contamination may not exceed the limits set forth in Table 9 and must be determined by either:
(i) Wiping an area of 300 cm 2 of the surface concerned with an absorbent material, using moderate pressure, and measuring the activity on the wiping material. Sufficient measurements must be taken in the most appropriate locations to yield a representative assessment of the non-fixed contamination levels. The amount of radioactivity measured on any single wiping material, divided by the surface area wiped and divided by the efficiency of the wipe procedure (the fraction of non-fixed contamination transferred from the surface to the absorbent material), may not exceed the limits set forth in Table 9 at any time during transport. For this purpose the actual wipe efficiency may be used, or the wipe efficiency may be assumed to be 0.10; or
(ii) Alternatively, the level of non-fixed contamination may be determined by using other methods of equal or greater efficiency.
(2) A conveyance used for non-exclusive use shipments is not required to be surveyed unless there is reason to suspect that it may exhibit contamination.
Table 9 is as follows:
Table 9—Non-Fixed External Radioactive Contamination Limits for Packages
(b) In the case of packages transported as exclusive use shipments by rail or public highway only, except as provided in paragraph (d) of this section, at any time during transport the non-fixed contamination on the external surface of any package, as well as on the associated accessible internal surfaces of any conveyance, overpack, or freight container, may not exceed ten times the levels prescribed in paragraph (a) of this section. The levels at the beginning of transport may not exceed the levels prescribed in paragraph (a) of this section.
(c) Except as provided in paragraphs (a) and (d) of this section, each conveyance, overpack, freight container, tank, or intermediate bulk container used for transporting Class 7 (radioactive) materials as an exclusive use shipment that utilizes the provisions of paragraph (b) of this section, § 173.427(b)(4), or § 173.427(c) must be surveyed with appropriate radiation detection instruments after each exclusive use transport. Except as provided in paragraphs (a) and (d) of this section, these items may not be returned to Class 7 (radioactive) materials exclusive use transport service, and then only for a subsequent exclusive use shipment utilizing one of the above cited provisions, unless the radiation dose rate at each accessible surface is 0.005 mSv per hour (0.5 mrem per hour) or less, and there is no significant non-fixed surface contamination as specified in paragraph (a) of this section. The requirements of this paragraph do not address return to service of items outside of the above cited provisions.
(d) Paragraphs (b) and (c) of this section do not apply to any closed transport vehicle used solely for the exclusive use transportation by highway or rail of Class 7 (radioactive) material with contamination levels that do not exceed ten times the levels prescribed in paragraph (a) of this section if—
(1) A survey of the interior surfaces of the empty vehicle shows that the radiation dose rate at any point does not exceed 0.1 mSv/h (10 mrem/h) at the surface or 0.02 mSv/h (2 mrem/h) at 1 m (3.3 feet) from the surface;
(2) Each vehicle is marked (e.g. stenciled) with the words “For Radioactive Materials Use Only” in letters at least 76 millimeters (3 inches) high in a conspicuous place on both sides of the exterior of the vehicle; and
(3) Each vehicle is kept closed except for loading or unloading; and
(4) Each vehicle is placarded in accordance with subpart F of part 172 of this subchapter.
(e) If it is evident that a package of radioactive material, or conveyance carrying unpackaged radioactive material, is leaking, or if it is suspected that the package, or conveyance carrying unpackaged material, may have leaked, access to the package or conveyance must be restricted and, as soon as possible, the extent of contamination and the resultant radiation level of the package or conveyance must be assessed. The scope of the assessment must include, as applicable, the package, the conveyance, the adjacent loading and unloading areas, and, if necessary, all other material which has been carried in the conveyance. When necessary, additional steps for the protection of persons, property, and the environment must be taken to overcome and minimize the consequences of such leakage. Packages, and conveyances carrying unpackaged material, which are leaking radioactive contents in excess of limits for normal conditions of transport may be removed to an interim location under supervision, but must not be forwarded until repaired or reconditioned and decontaminated, or as approved by the Associate Administrator.
§ 173.447   Storage incident to transportation—general requirements.
The following requirements apply to temporary storage during the course of transportation but not to Nuclear Regulatory Commission or Agreement State-licensed facilities or U.S. Government-owned or contracted facilities.
(a) The number of packages and overpacks bearing FISSILE labels stored in any one storage area, such as a transit area, terminal building, storeroom, waterfront pier, or assembly yard, must be limited so that the total sum of the criticality safety indices in any individual group of such packages and overpacks does not exceed 50. Groups of such packages and overpacks must be stored so as to maintain a spacing of at least 6 m (20 feet) from all other groups of such packages and overpacks.
(b) Storage requirements for Class 7 (radioactive) material transported in vessels are described in subpart M of part 176 of this subchapter.
§ 173.448   General transportation requirements.
(a) Each shipment of Class 7 (radioactive) materials must be secured to prevent shifting during normal transportation conditions.
(b) Except as provided in §§ 174.81, 176.83, and 177.848 of this subchapter, or as otherwise required by the Competent Authority in the applicable certificate, a package or overpack of Class 7 (radioactive) materials may be carried among packaged general cargo without special stowage provisions, if—
(1) The heat output in watts does not exceed 0.1 times the minimum package dimension in centimeters; or
(2) The average surface heat flux of the package or overpack does not exceed 15 watts per square meter and the immediately surrounding cargo is not in sacks or bags or otherwise in a form that would seriously impede air circulation for heat removal.
(c) Packages or overpacks bearing labels prescribed in § 172.403 of this subchapter may not be carried in compartments occupied by passengers, except in those compartments exclusively reserved for couriers accompanying those packages.
(d) Mixing of different kinds of packages that include fissile packages is authorized only in accordance with § 173.459.
(e) No person shall offer for transportation or transport aboard a passenger-carrying aircraft any single package or overpack with a transport index greater than 3.0.
(f) No person shall offer for transportation or transport aboard a passenger-carrying aircraft any Class 7 (radioactive) material unless that material is intended for use in, or incident to, research, medical diagnosis or treatment.
(g) If an overpack is used to consolidate individual packages or to enclose a single package of Class 7 (radioactive) materials, the package(s) must comply with the packaging, marking, and labeling requirements of this subchapter, and:
(1) The overpack must be labeled as prescribed in § 172.403(h) of this subchapter;
(2) The overpack must be marked as prescribed in subpart D of part 172 of this subchapter and § 173.25(a); and
(3) The transport index of the overpack may not exceed 3.0 for passenger-carrying aircraft shipments, or 10.0 for cargo-aircraft shipments.
§ 173.453   Fissile materials—exceptions.
Fissile materials meeting the requirements of at least one of the paragraphs (a) through (f) of this section are excepted from the requirements of this subpart for fissile materials, including the requirements of §§ 173.457 and 173.459, but are subject to all other requirements of this subpart, except as noted.
(a) An individual package containing 2 grams or less of fissile material.
(b) An individual or bulk packaging containing 15 grams or less of fissile material provided the package has at least 200 grams of solid nonfissile material for every gram of fissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass for solid nonfissile material.
(c) Low concentrations of solid fissile material commingled with solid nonfissile material, provide that:
(1) There is at least 2000 grams of nonfissile material for every gram of fissile material, and
(2) There is no more than 180 grams of fissile material distributed within 360 kg of contiguous nonfissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass of solid nonfissile material.
(d) Uranium enriched in uranium-235 to a maximum of 1 percent by weight, and with total plutonium and uranium-233 content of up to 1 percent of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitute less than 5 percent of the uranium mass.
(e) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of 2 percent by mass, with a total plutonium and uranium-233 content not exceeding 0.002 percent of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of 2. The material must be contained in at least a DOT Type A package.
(f) Packages containing, individually, a total plutonium mass of not more than 1000 grams, of which not more than 20 percent by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.
§ 173.457   Transportation of fissile material packages—specific requirements.
(a) Packages containing fissile radioactive material which are not excepted under § 173.453 must be assigned by the offeror, in accordance with their definitions in § 173.403, a criticality safety index (CSI) and a transport index (TI).
(b) Fissile material packages and conveyances transporting fissile material packages must satisfy the radiation level restrictions of § 173.441.
(c) Except for consignments under exclusive use, the CSI of any package or overpack may not exceed 50. A fissile material package with CSI greater than 50 must be transported by exclusive use.
(d) For non-exclusive use shipments of fissile material packages, except on vessels, the total sum of CSI's in a freight container or on a conveyance may not exceed 50.
(e) For exclusive use shipments of fissile material packages, except on vessels, the total sum of CSI's in a freight container or on a conveyance may not exceed 100.
(f) Exclusive use shipments of fissile material packages must satisfy the radiation level and administrative requirements of § 173.441(b).
(g) The number of packages, overpacks and freight containers containing fissile material stored in transit in any one storage area must be so limited that the total sum of the CSI's in any group of packages, overpacks or freight containers does not exceed 50. Groups of packages shall be stored so as to maintain a spacing of a least 6 m (20 ft) between the closest surfaces of any two groups.
(h) Provisions for shipment by vessel of Class 7 (radioactive) material packages, including fissile material packages by vessel are described in §§ 176.700-176.720 of this subchapter.
§ 173.459   Mixing of fissile material packages with non-fissile or fissile-excepted material packages.
Mixing of fissile material packages with other types of Class 7 (radioactive) materials in any conveyance or storage location is authorized only if the TI of any single package does not exceed 10, the CSI of any single package does not exceed 50, and the provisions of §§ 173.441 and 173.457 are satisfied.
§ 173.461   Demonstration of compliance with tests.
(a) Compliance with the design requirements in § 173.412 and the test requirements in §§ 173.465 through 173.469 must be shown by any of the methods prescribed in this paragraph, or by a combination of these methods appropriate for the particular feature being evaluated:
(1) Performance of tests with prototypes or samples of the specimens representing LSA-III, special form Class 7 (radioactive) material, or packaging, in which case the contents of the packaging for the test must simulate as closely as practicable the expected range of physical properties of the radioactive contents or packaging to be tested, must be prepared as normally presented for transport. The use of non-radioactive substitute contents is encouraged provided that the results of the testing take into account the radioactive characteristics of the contents for which the package is being tested;
(2) Reference to a previous, satisfactory demonstration of compliance of a sufficiently similar nature;
(3) Performance of tests with models of appropriate scale incorporating those features that are significant with respect to the item under investigation, when engineering experience has shown results of those tests to be suitable for design purposes. When a scale model is used, the need for adjusting certain test parameters, such as the penetrator diameter or the compressive load, must be taken into account; or
(4) Calculations or reasoned evaluation, using reliable and conservative procedures and parameters.
(b) With respect to the initial conditions for the tests under §§ 173.465 through 173.469, except for the water immersion tests, compliance must be based upon the assumption that the package is in equilibrium at an ambient temperature of 38 °C (100 °F).
§ 173.462   Preparation of specimens for testing.
(a) Each specimen (i.e., sample, prototype or scale model) must be examined before testing to identify and record faults or damage, including:
(1) Divergence from the specifications or drawings;
(2) Defects in construction;
(3) Corrosion or other deterioration; and
(4) Distortion of features.
(b) Any deviation found under paragraph (a) of this section from the specified design must be corrected or appropriately taken into account in the subsequent evaluation.
(c) The containment system of the packaging must be clearly specified.
(d) The external features of the specimen must be clearly identified so that reference may be made to any part of it.
§ 173.465   Type A packaging tests.
(a) The packaging, with contents, must be capable of withstanding the water spray, free drop, stacking and penetration tests prescribed in this section. One prototype may be used for all tests if the requirements of paragraph (b) of this section are met. The tests are successful if the requirements of § 173.412(j) are met.
(b) Water spray test. The water spray test must precede each test or test sequence prescribed in this section. The water spray test must simulate exposure to rainfall of approximately 5 cm (2 inches) per hour for at least one hour. The time interval between the end of the water spray test and the beginning of the next test must be such that the water has soaked in to the maximum extent without appreciable drying of the exterior of the specimen. In the absence of evidence to the contrary, this interval may be assumed to be two hours if the water spray is applied from four different directions simultaneously. However, no time interval may elapse if the water spray is applied from each of the four directions consecutively.
(c) Free drop test. The specimen must drop onto the target so as to suffer maximum damage to the safety features being tested, and:
(1) The height of the drop measured from the lowest point of the specimen to the upper surface of the target may not be less than the distance specified in table 10, for the applicable package mass. The target must be as specified in § 173.465(c)(5). Table 10 is as follows:
Table 10—Free Drop Distance for Testing Packages to Normal Conditions of Transport
(2) For packages containing fissile material, the free drop test specified in paragraph (c)(1) of this section must be preceded by a free drop from a height of 0.3 m (1 foot) on each corner, or in the case of cylindrical packages, onto each of the quarters of each rim.
(3) For fiberboard or wood rectangular packages with a mass of 50 kg (110 pounds) or less, a separate specimen must be subjected to a free drop onto each corner from a height of 0.3 m (1 foot).
(4) For cylindrical fiberboard packages with a mass of 100 kg (220 pounds) or less, a separate specimen must be subjected to a free drop onto each of the quarters of each rim from a height of 0.3 m (1 foot).
(5) The target for the free drop test must be a flat, horizontal surface of such mass and rigidity that any increase in its resistance to displacement or deformation upon impact by the specimen would not significantly increase the damage to the specimen.
(d) Stacking test. (1) The specimen must be subjected for a period of at least 24 hours to a compressive load equivalent to the greater of the following:
(i) A total weight equal to five times the maximum weight of the package; or
(ii) The equivalent of 13 kilopascals (1.9 psi) multiplied by the vertically projected area of the package.
(2) The compressive load must be applied uniformly to two opposite sides of the specimen, one of which must be the base on which the package would normally rest.
(e) Penetration test. For the penetration test, the specimen must be placed on a rigid, flat, horizontal surface that will not move significantly while the test is being performed.
(1) A bar of 3.2 cm (1.25 inches) in diameter with a hemispherical end and a mass of 6 kg (13.2 pounds) must be dropped and directed to fall with its longitudinal axis vertical, onto the center of the weakest part of the specimen, so that, if it penetrates far enough, it will hit the containment system. The bar may not be significantly deformed by the test; and
(2) The height of the drop of the bar measured from its lower end to the intended point of impact on the upper surface of the specimen must be 1 m (3.3 feet) or greater.
§ 173.466   Additional tests for Type A packagings designed for liquids and gases.
(a) In addition to the tests prescribed in § 173.465, Type A packagings designed for liquids and gases must be capable of withstanding the following tests in this section. The tests are successful if the requirements of § 173.412(k) are met.
(1) Free drop test. The packaging specimen must drop onto the target so as to suffer the maximum damage to its containment. The height of the drop measured from the lowest part of the packaging specimen to the upper surface of the target must be 9 m (30 feet) or greater. The target must be as specified in § 173.465(c)(5).
(2) Penetration test. The specimen must be subjected to the test specified in § 173.465(e) except that the height of the drop must be 1.7 m (5.5 feet).
(b) [Reserved]
§ 173.467   Tests for demonstrating the ability of Type B and fissile materials packagings to withstand accident conditions in transportation.
Each Type B packaging or packaging for fissile material must meet the test requirements prescribed in 10 CFR part 71 for ability to withstand accident conditions in transportation.
§ 173.468   Test for LSA-III material.
(a) LSA-III Class 7 (radioactive) material must meet the test requirement of paragraph (b) of this section. Any differences between the material to be transported and the test material must be taken into account in determining whether the test requirements have been met.
(b) Test method. (1) The specimen representing no less than the entire contents of the package must be immersed for 7 days in water at ambient temperature.
(2) The volume of water to be used in the test must be sufficient to ensure that at the end of the test period the free volume of the unabsorbed and unreacted water remaining will be at least 10% of the volume of the specimen itself.
(3) The water must have an initial pH of 6-8 and a maximum conductivity of 10 micromho/cm at 20 °C (68 °F).
(4) The total activity of the free volume of water must be measured following the 7 day immersion test and must not exceed 0.1 A 2 .
§ 173.469   Tests for special form Class 7 (radioactive) materials.
(a) Special form Class 7 (radioactive) materials must meet the test requirements of paragraph (b) of this section. Each solid Class 7 (radioactive) material or capsule specimen to be tested must be manufactured or fabricated so that it is representative of the actual solid material or capsule that will be transported with the proposed radioactive content duplicated as closely as practicable. Any differences between the material to be transported and the test material, such as the use of non-radioactive contents, must be taken into account in determining whether the test requirements have been met. The following additional conditions apply:
(1) A different specimen may be used for each of the tests;
(2) The specimen may not break or shatter when subjected to the impact, percussion, or bending tests;
(3) The specimen may not melt or disperse when subjected to the heat test; and
(4) After each test, leaktightness or indispersibility of the specimen must be determined by—
(i) A method no less sensitive than the leaching assessment prescribed in paragraph (c) of this section. For a capsule resistant to corrosion by water, and which has an internal void volume greater than 0.1 milliliter, an alternative to the leaching assessment is a demonstration of leaktightness of 10 −4 torr-1/s (1.3 × 10 −4 atm-cm 3 /s) based on air at 25 °C (77 °F) and one atmosphere differential pressure for solid radioactive content, or 10 −6 torr-1/s (1.3 × 10 −6 atm-cm 3 /s) for liquid or gaseous radioactive content; or
(ii) A specimen that comprises or simulates Class 7 (radioactive) material contained in a sealed capsule need not be subjected to the leaching assessment specified in paragraph (c) of this section provided it is alternatively subjected to any of the volumetric leakage assessment tests prescribed in the International Organization for Standardization document ISO 9978-1992(E): “Radiation protection—Sealed radioactive sources—Leakage test methods” (IBR, see § 171.7 of this subchapter).
(b) Test methods —(1) Impact Test. The specimen must fall onto the target from a height of 9 m (30 feet) or greater. The target must be as specified in § 173.465(c)(5).
(2) Percussion Test. (i) The specimen must be placed on a sheet of lead that is supported by a smooth solid surface, and struck by the flat face of a steel billet so as to produce an impact equivalent to that resulting from a free drop of 1.4 kg (3 pounds) through 1 m (3.3 feet).
(ii) The flat face of the billet must be 2.5 cm (1 inch) in diameter with the edge rounded off to a radius of 3 mm ±0.3 mm (0.12 inch ±0.012 inch).
(iii) The lead must be of hardness number 3.5 to 4.5 on the Vickers scale and thickness not more than 25 mm (1 inch), and must cover an area greater than that covered by the specimen.
(iv) A fresh surface of lead must be used for each impact.
(v) The billet must strike the specimen so as to cause maximum damage.
(3) Bending test. (i) This test applies only to long, slender sources with a length of 10 cm (4 inches) or greater and a length to width ratio of 10 or greater.
(ii) The specimen must be rigidly clamped in a horizontal position so that one half of its length protrudes from the face of the clamp.
(iii) The orientation of the specimen must be such that the specimen will suffer maximum damage when its free end is struck by the flat face of a steel billet.
(iv) The billet must strike the specimen so as to produce an impact equivalent to that resulting from a free vertical drop of 1.4 kg (3 pounds) through 1 m (3.3 feet).
(v) The flat face of the billet must be 2.5 cm (1 inch) in diameter with the edges rounded off to a radius of 3 mm ±0.3 mm (.12 inch ±0.012 inch).
(4) Heat test. The specimen must be heated in air to a temperature of not less than 800 °C (1475 °F), held at that temperature for a period of 10 minutes, and then allowed to cool.
(c) Leaching assessment methods. (1) For indispersible solid material—
(i) The specimen shall be immersed for seven days in water at ambient temperature. The volume of water to be used in the test shall be sufficient to ensure that at the end of the seven day test period the free volume of the unabsorbed and unreacted water remaining shall be at least 10% of the volume of the solid test sample itself. The water shall have an initial pH of 6-8 and a maximum conductivity of 1 mS/m (10 micromho/cm) at 20 °C (68 °F).
(ii) The water with specimen must then be heated to a temperature of 50 °C ±5° (122 °F ±9°) and maintained at this temperature for four hours.
(iii) The activity of the water must then be determined.
(iv) The specimen shall then be kept for at least seven days in still air at not less than 30 °C (86 °F) and relative humidity not less than 90%.
(v) The specimen must then be immersed in water under the same conditions as in paragraph (c)(1)(i) of this section, and the water with specimen must be heated to 50 C ±5° (122 °F ±9°) and maintained at that temperature for four hours.
(vi) The activity of the water must then be determined. The activities determined in paragraph (c)(1)(iii) of this section and this paragraph, (c)(1)(vi), may not exceed 2 kilobecquerels (0.05 microcurie).
(2) For encapsulated material—
(i) The specimen shall be immersed in water at ambient temperature. The water shall have an initial pH of 6-8 and a maximum conductivity of 1 mS/m (10 micromho/cm) at 20 °C (68 °F).
(ii) The water and specimen must be heated to a temperature of 50 °C ±5° (122 °F ±9°) and maintained at this temperature for four hours.
(iii) The activity of the water must then be determined.
(iv) The specimen shall then be kept for at least seven days in still air at not less than 30 °C (86 °F) and relative humidity not less than 90%.
(v) The process in paragraphs (c)(2)(i), (c)(2)(ii), and (c)(2)(iii) of this section must be repeated.
(vi) The activity determined in paragraph (c)(2)(iii) of this section may not exceed 2 kilobecquerels (0.05 microcurie).
(d) A specimen that comprises or simulates Class 7 (radioactive) material contained in a sealed capsule need not be subjected to—
(1) The impact test and the percussion test of this section provided that the mass of the special form material is—
(i) Less than 200 g and it is alternatively subjected to the Class 4 impact test prescribed in ISO 2919 (IBR, see § 171.7 of this subchapter), or
(ii) Less than 500 g and it is alternatively subjected to the Class 5 impact test prescribed in ISO 2919 (IBR, see § 171.7 of this subchapter); and
(2) The heat test of this section, provided the specimen is alternatively subjected to the Class 6 temperature test specified in the International Organization for Standardization document ISO 2919 (IBR, see § 171.7 of this subchapter).
(e) Special form materials that were successfully tested prior to October 1, 2014 in accordance with the requirements of paragraph (d) of this section in effect prior to October 1, 2014 may continue to be offered for transportation and transported without additional testing under this section.
§ 173.471   Requirements for U.S. Nuclear Regulatory Commission approved packages.
In addition to the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) and other requirements of this subchapter, any offeror of a Type B(U), Type B(M), or fissile material package that has been approved by the NRC in accordance with 10 CFR part 71 must also comply with the following requirements:
(a) The offeror shall be registered with the USNRC as a party to the packaging approval, and make the shipment in compliance with the terms of the packaging approval;
(b) The outside of each package must be durably and legibly marked with the package identification marking indicated in the USNRC packaging approval;
(c) Each shipping paper related to the shipment of the package must bear the package identification marking indicated in the USNRC packaging approval;
(d) Before export shipment of the package, the offeror shall obtain a U.S. Competent Authority Certificate for that package design, or if one has already been issued, the offeror shall register in writing (including a description of the quality assurance program required by 10 CFR part 71) with the U.S. Competent Authority as a user of the certificate. ( Note: The person who originally applies for a U.S. Competent Authority Certificate will be registered automatically.) The registration request must be sent to the Associate Administrator for Hazardous Materials Safety (PHH-23), Department of Transportation, East Building, 1200 New Jersey Avenue, SE., Washington DC 20590-0001. Alternatively, the application with any attached supporting documentation in an appropriate format may be submitted by facsimile (fax) to (202) 366-3753 or (202) 366-3650, or by electronic mail (e-mail) to “ ramcert@dot.gov. ” Upon registration, the offeror will be furnished with a copy of the certificate. The offeror shall then submit a copy of the U.S. Competent Authority Certificate applying to that package design to the national competent authority of each country into or through which the package will be transported, unless the offeror has documentary evidence that a copy has already been furnished; and
(e) Each request for a U.S. Competent Authority Certificate as required by the IAEA regulations must be submitted in writing to the Associate Administrator. The request must be in triplicate and include copies of the applicable USNRC packaging approval, USNRC Quality Assurance Program approval number, and a reproducible 22 cm × 30 cm (8.5″ × 11″) drawing showing the make-up of the package. The request and accompanying documentation must be sent to the Associate Administrator for Hazardous Materials Safety (PHH-23), Department of Transportation, East Building, 1200 New Jersey Avenue, SE., Washington DC 20590-0001. Alternatively, the application with any attached supporting documentation in an appropriate format may be submitted by facsimile (fax) to (202) 366-3753 or (202) 366-3650, or by electronic mail (e-mail) to “ ramcert@dot.gov. ” Each request is considered in the order in which it is received. To allow sufficient time for consideration, requests must be received at least 90 days before the requested effective date.
§ 173.472   Requirements for exporting DOT Specification Type B and fissile packages.
(a) Any offeror who exports a DOT Specification Type B or fissile material package authorized by § 173.416 or § 173.417 shall comply with paragraphs (b) through (f) of this section.
(b) The shipment must be made in accordance with the conditions of the U.S. Certificate of Competent Authority.
(c) The outside of each package must be durably and legibly marked with the package identification marking indicated in the U.S. Competent Authority Certificate.
(d) Each shipping paper related to the shipment of the package must bear the package identification marking indicated in the U.S. Competent Authority Certificate.
(e) Before export of the package, the offeror shall obtain a U.S. Competent Authority Certificate for that package design, or if one has already been issued, the offeror shall register in writing (including a description of the quality assurance program required by 10 CFR part 71, subpart H, or 49 CFR 173.474 and 173.475) with the U.S. Competent Authority as a user of the certificate. Upon registration, the offeror will be furnished with a copy of the certificate. The offeror shall then submit a copy of the U.S. Competent Authority Certificate applying to that package design to the national competent authority of each country into or through which the package will be transported, unless the offeror has documentary evidence that a copy has already been furnished.
(f) Each request for a U.S. Competent Authority Certificate as required by the IAEA regulations must be submitted in writing to the Associate Administrator. The request must be in triplicate and must include a description of the quality assurance program required by 10 CFR part 71, subpart H, or 49 CFR 173.474 and 173.475, and a reproducible 22 cm × 30 cm (8.5″ × 11″) drawing showing the make-up of the package. A copy of the USNRC quality assurance program approval will satisfy the requirement for describing the quality assurance program. The request and accompanying documentation may be sent by mail or other delivery service. Alternatively, the request with any attached supporting documentation submitted in an appropriate format may be sent by facsimile (fax) to (202) 366-3753 or (202) 366-3650, or by electronic mail (e-mail) to “ ramcert@dot.gov. ” Each request is considered in the order in which it is received. To allow sufficient time for consideration, requests must be received at least 90 days before the requested effective date.
§ 173.473   Requirements for foreign-made packages.
In addition to other applicable requirements of this subchapter, each offeror of a foreign-made Type B(U), Type B(M), Type C, Type CF, Type H(U), Type H(M), or fissile material package for which a Competent Authority Certificate is required by IAEA's “Regulations for the Safe Transport of Radioactive Material, SSR-6, ” (IBR, see § 171.7 of this subchapter) shall also comply with the following requirements:
(a) Prior to the shipment of such a package of Class 7 (radioactive) materials into or from the U.S., the offeror shall—
(1) Have the foreign competent authority certificate revalidated by the U.S. Competent Authority, unless this has been done previously. Each request for revalidation must be in triplicate, contain all the information required by Section VIII of the IAEA regulations in “IAEA Regulations for the Safe Transport of Radioactive Material, SSR-6” (IBR, see § 171.7 of this subchapter), and include a copy in English of the foreign competent authority certificate. The request and accompanying documentation must be sent to the Associate Administrator for Hazardous Materials Safety (PHH-23), Department of Transportation, East Building, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Alternatively, the request with any attached supporting documentation submitted in an appropriate format may be sent by facsimile (fax) to (202) 366-3753 or (202) 366-3650, or by electronic mail to “ramcert@dot.gov.” Each request is considered in the order in which it is received. To allow sufficient time for consideration, requests must be received at least 90 days before the requested effective date;
(2) Register in writing with the U.S. Competent Authority as a user of the package covered by the foreign competent authority certificate and its U.S. revalidation. Alternatively, the registration request with any attached supporting documentation submitted in an appropriate format may be sent by facsimile (fax) to (202) 366-3753 or (202) 366-3650, or by electronic mail (e-mail) to “ ramcert@dot.gov. ” If the offeror is requesting the revalidation, registration is automatic; and
(3) Supply to the carrier, upon request, the applicable competent authority certificates. However, the competent authority certificates are not required to accompany the packages to which they apply.
(b) The outside of each package must be durably and legibly marked with the competent authority identification marking indicated on the Competent Authority Certificate and revalidation.
(c) Each shipping paper for a shipment of Class 7 (radioactive) materials must bear a notation of the package identification marking indicated on the competent authority certificate or revalidation.
(d) All requirements of the foreign competent authority certificate and the U.S. Competent Authority revalidation must be fulfilled.
§ 173.474   Quality control for construction of packaging.
Prior to the first use of any packaging for the shipment of Class 7 (radioactive) material, the offeror shall determine that—
(a) The packaging meets the quality of design and construction requirements as specified in this subchapter; and
(b) The effectiveness of the shielding, containment and, when required, the heat transfer characteristics of the package, are within the limits specified for the package design.
§ 173.475   Quality control requirements prior to each shipment of Class 7 (radioactive) materials.
Before each shipment of any Class 7 (radioactive) materials package, the offeror must ensure, by examination or appropriate tests, that—
(a) The packaging is proper for the contents to be shipped;
(b) The packaging is in unimpaired physical condition, except for superficial marks;
(c) Each closure device of the packaging, including any required gasket, is properly installed, secured, and free of defects;
(d) For fissile material, each moderator and neutron absorber, if required, is present and in proper condition;
(e) Each special instruction for filling, closing, and preparation of the packaging for shipment has been followed;
(f) Each closure, valve, or other opening of the containment system through which the radioactive content might escape is properly closed and sealed;
(g) Each packaging containing liquid in excess of an A 2 quantity and intended for air shipment has been tested to show that it will not leak under an ambient atmospheric pressure of not more than 25 kPa, absolute (3.6 psia). The test must be conducted on the entire containment system, or on any receptacle or vessel within the containment system, to determine compliance with this requirement;
(h) The internal pressure of the containment system will not exceed the design pressure during transportation; and
(i) External radiation and contamination levels are within the allowable limits specified in this subchapter.
§ 173.476   Approval of special form Class 7 (radioactive) materials.
(a) Each offeror of special form Class 7 (radioactive) materials must maintain on file for at least two years after the offeror's latest shipment, and provide to the Associate Administrator on request, a complete safety analysis, including documentation of any tests, demonstrating that the special form material meets the requirements of § 173.469. An IAEA Certificate of Competent Authority issued for the special form material may be used to satisfy this requirement.
(b) Prior to the first export shipment of a special form Class 7 (radioactive) material from the United States, each offeror shall obtain a U.S. Competent Authority Certificate for the specific material. For special form material manufactured outside the United States, an IAEA Certificate of Competent Authority from the country of origin may be used to meet this requirement.
(c) Each request for a U.S. Competent Authority Certificate as required by the IAEA regulations must be submitted in writing, in triplicate, by mail or other delivery service to the Associate Administrator. Alternatively, the request with any attached supporting documentation submitted in an appropriate format may be sent by facsimile (fax) to (202) 366-3753 or (202) 366-3650, or by electronic mail (e-mail) to “ ramcert@dot.gov. ”. Each request is considered in the order in which it is received. To allow sufficient time for consideration, requests must be received at least 90 days before the requested effective date. Each petition for a U.S. Competent Authority Certificate must include the following information:
(1) A detailed description of the material, or if a capsule, a detailed description of the contents. Particular reference must be made to both physical and chemical states;
(2) A detailed statement of the capsule design and dimensions, including complete engineering drawings [22cm × 30cm (8 1/2 inches × 11 inches)] and schedules of material, and methods of construction;
(3) A statement of the tests that have been made and their results; or evidence based on calculative methods to show that the material is able to pass the tests; or other evidence that the special form Class 7 (radioactive) material complies with § 173.469;
(4) For the original request for a Competent Authority Certificate, evidence of a quality assurance program based on international, national or other standards, for the design, manufacture, testing, documentation, use, maintenance and inspection, as appropriate, of all special form material offered for transport by the requester; and
(5) A description of any proposed pre-shipment actions, such as leak testing, for use in the consignment of special form radioactive material for transport.
(d) Paragraphs (a) and (b) of this section do not apply in those cases where A 1 equals A 2 and the material is not required to be described on the shipping papers as “Radioactive Material, Type A Package, Special Form” or as “Radioactive Material, Type A Package, Special Form, Fissile.”
§ 173.477   Approval of packagings containing greater than 0.1 kg of non-fissile or fissile-excepted uranium hexafluoride.
(a) Each offeror of a package containing more than 0.1 kg of uranium hexafluoride must maintain on file for at least two years after the offeror's latest shipment, and provide to the Associate Administrator on request, a complete safety analysis, including documentation of any tests, demonstrating that the package meets the requirements of § 173.420. An IAEA Certificate of Competent Authority issued for the design of the packaging containing greater than 0.1 kg of non-fissile or fissile-exempted uranium hexafluoride may be used to satisfy this requirement.
(b) Prior to the first export shipment of a package containing greater than 0.1 kg of uranium hexafluoride from the United States, each offeror shall obtain a U.S. Competent Authority Certificate for the packaging design. For packagings manufactured outside the United States, each offeror shall comply with § 173.473.
(c) Each request for a U.S. Competent Authority Certificate as required by the IAEA regulations must be submitted in writing, in triplicate, by mail or other delivery service to the Associate Administrator. Alternatively, the request with any attached supporting documentation submitted in an appropriate format may be sent by facsimile (fax) to (202) 366-3753 or (202) 366-3650, or by electronic mail (e-mail) to ramcert@dot.gov. Each request is considered in the order in which it is received. To allow sufficient time for consideration, requests must be received at least 90 days before the requested effective date. Each request for a U.S. Competent Authority Certificate must include the following information:
(1) A safety analysis report which, at a minimum, provides a detailed description of the packaging and contents; a description of the manufacturing process used for the packaging; and details of the tests conducted and copy of their results, evidence based on calculative methods to show that the package is able to pass the tests, or other evidence that the package complies with § 173.420; and
(2) For the original request for a Competent Authority Certificate, evidence of a quality assurance program.